Clinical trial operations leaders face increasing demands in 2019:

Trial Complexity Has Doubled

The number of data points per trial increased by 88% over the last decade.1 More stringent reporting and inspection readiness regulations compound this increasing complexity of trials.

A Growing Focus on Stricter Compliance

Regulatory bodies are stepping up their requirements on sponsors —and principal investigators— as reflected in the ratification of ICH GCP E6(R2), to ensure proper oversight operations.2

Increasing Pressure for Multi-Site Trials

Multi-site studies are becoming standard as the number of enrolling sites increased by 63% over the last decade, with the number of enrolling patients per site dropping by 18%.3

In response to these demands, clinical trial operation leaders have four key expectations to meet in 2019:

1. Increase study capacity with limited resources.

The most successful clinical trial operations leaders in 2019 will be those who can take on more studies without increasing their budgets or staff. This ability to scale requires maximizing operational efficiency through streamlined work-flows, new technology, marshaling resources, and training staff.

2. Drive process standardization across the organization.

Clinical trial operations professionals who can successfully drive process standardization across the organization through embracing new technology and effectively training all stakeholders will be key leaders in 2019. Ensuring buy-in from historically risk-adverse users, like investigators, will require a focused approach.

3. Streamline systems and processes to accelerate operations.

Clinical trial operations leaders must invest time in 2019 to evaluate current systems and processes to analyze where technology can streamline, automate, and accelerate operations. Work with a vendor who is focused on your strategic goals to uncover potential workflow adjustments.

4. Position the center as a site of choice with sponsors

With 72% of studies experiencing delays of at least a month, costing sponsors up to $8 million for each day4, the ability to harness technology to maximize site operational efficiency will lead sites that deliver to be a “site of choice.” Clinical trial operations leaders will be expected in 2019 to be able to report on studies accurately, have easy-to-use remote monitoring capabilities, and maintain proactive inspection readiness.

Download the full report “Four Strategies Clinical Trial Operations Leaders can use to Advance Research in 2019.”